(83 days)
KTT
Not Found
No
The document does not mention AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The 'Intended Use / Indications for Use' section describes the device's purpose in treating various medical conditions, such as post-traumatic joint contracture, fractures, pseudoarthrosis, and limb lengthening, which are therapeutic applications.
No
Explanation: The device description indicates it is a reprocessed external fixation device used for treating conditions like joint contractures, fractures, and deformities. It is a therapy device, not a diagnostic one.
No
The device description explicitly states it consists of physical components like rods, rings, plates, and posts, which are hardware elements of an external fixation system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in treating musculoskeletal conditions like joint contractures, fractures, and deformities. This is a therapeutic and structural application, not a diagnostic one performed on in vitro samples.
- Device Description: The device is described as an external fixation system consisting of rods, rings, plates, and posts. These are physical components used to stabilize and manipulate bone and soft tissue. This is consistent with a medical device used for treatment, not an IVD used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such testing. The focus is entirely on the mechanical and structural function of the external fixation system.
Therefore, this device falls under the category of a medical device used for treatment and structural support, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Post-traumatic joint contracture which has resulted in loss of range of motion. .
- Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction.
- Open and closed fracture fixation. .
- Pseudoarthrosis of long bones.
- Limb lengthening by epiphyseal or metaphyseal distraction. .
- Correction of bony or soft tissue deformities. ●
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis.
- Infected fractures or nonunions. .
- Management of comminuted intra-articular fractures of the distal radius.
Product codes
KTT
Device Description
SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods, articulating and telescoping components), and connection elements (rings, plates, and posts) contained in the original manufacturer's system. Some of the components are MR safe and made of non-magnetic materials. MR safe components are intended for use in the MR environment. Note: Only the non-patient contact, external frame elements are the subject of this submission, the anchorage pins and wire elements are not included in the scope of this submission
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Representative samples of reprocessed external fixation constructs were tested to demonstrate appropriate functional characteristics. Process validation testing was performed to validate the cleaning procedure. In addition, the manufacturing process includes visual and validated functional testing of all products produced.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Smith & Nephew Original Ilizarov® External Fixation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
K083636 (pg 1/1)
STERILMED, INC.
Sterile & Disposable Medical Devices
A.
National Endowment for Financial Education
510(K) PREMARKET NOTIFICATION SUBMISSION DECEMBER 8, 2008 For Reprocessed External Fixation Devices
SUMMARY AND CERTIFICATION 11.
510(k) Summary
MAR - 2 2009
| Submitter: | SterilMed, Inc. |
|---|---|
| Contact Person: | Garrett Ahlborg |
| 11400 73rd Avenue North | |
| Maple Grove, MN 55369 | |
| Ph: 763-488-3483 | |
| Fax: 763-488-3350 | |
| Email: gahlborg@sterilmed.com | |
| Date Prepared: | December 8, 2008 |
| Trade Name: | Reprocessed External Fixation device |
| Classification Name: | Single/multiple component metallic bone fixation appliances and accessories. |
| Classification Number: | Class II, 21 CFR 888.3030 |
| Product Code: | KTT |
| Predicate
Device: | The reprocessed external fixation device is substantially equivalent to the Smith & Nephew
Original Ilizarov® External Fixation System. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description: | SterilMed's reprocessed external fixation devices consist of the standard bridge elements (rods,
articulating and telescoping components), and connection elements (rings, plates, and posts)
contained in the original manufacturer's system. Some of the components are MR safe and
made of non-magnetic materials. MR safe components are intended for use in the MR
environment.
Note: Only the non-patient contact, external frame elements are the subject of this submission,
the anchorage pins and wire elements are not included in the scope of this submission |
| Intended Use: | Post-traumatic joint contracture which has resulted in loss of range of motion: fractures and
disease which generally may result in joint contractures or loss of range of motion and fractures
requiring distraction: open and closed fracture fixation; pseudoarthrosis of long bones; limb
lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue
deformities: correction of segmental bony or soft tissue defects; joint arthrodesis; infected
fractures or nonunions and management of comminuted intra-articular fractures of the distal
radius. |
| Functional and
Safety Testing: | Representative samples of reprocessed external fixation constructs were tested to demonstrate
appropriate functional characteristics. Process validation testing was performed to validate the
cleaning procedure. In addition, the manufacturing process includes visual and validated
functional testing of all products produced. |
| Conclusion: | The Reprocessed External Fixation Devices are substantially equivalent to the Smith &
Nephew Original Ilizarov® external fixation devices.
This conclusion is based upon the devices` similarities in functional design (principle of
operation), materials, indications for use and methods of construction. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SterilMed, Inc. % Mr. Garrett Ahlborg Regulatory Affairs Specialist 11400 73rd Ave. North #100 Maple Grove, Minnesota 55369
MAR - 2 2009
Re: K083636
Trade/Device Name: Reprocessed External Fixation Device Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: December 8, 2008 Received: December 9, 2008
Dear Mr. Ahlborg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, ilisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 100-1000.
2
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): _ K083636
Device Name: Reprocessed External Fixation Device
Indications for Use:
- Post-traumatic joint contracture which has resulted in loss of range of motion. .
- Fractures and disease which generally may result in joint contractures or loss of range of motion and � fractures requiring distraction.
- Open and closed fracture fixation. .
- Pseudoarthrosis of long bones. �
- Limb lengthening by epiphyseal or metaphyseal distraction. .
- Correction of bony or soft tissue deformities. ●
- Correction of segmental bony or soft tissue defects. .
- Joint arthrodesis.
- Infected fractures or nonunions. .
- Management of comminuted intra-articular fractures of the distal radius.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 1083631